Gregory P Samsa

Duke University Medical Center, Durham, North Carolina, United States

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Publications (211)1099.01 Total impact

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    ABSTRACT: Patients with advanced non-small cell lung cancer (aNSCLC) face a significant symptom burden. Little is known about the frequency and severity of symptoms over time, so we longitudinally characterized patients' symptoms using the Patient Care Monitor (PCM) version 2.0, an electronic symptom-assessment tool. Ninety-seven patients with aNSCLC completed the PCM at up to four clinic visits. We analyzed symptom data by incidence, severity, type (functional vs. nonfunctional), proximity to death, and cancer anorexia-cachexia syndrome status (CACS). Functional concerns predominated, even in the non-CACS group. Average severity among the top 5 symptoms was worse for functional than nonfunctional items (mean difference 0.62, 95 % CI 0.22-1.01, P = 0.003). Severe dyspnea and fatigue were the most prevalent nonfunctional symptoms; moderate/severe dyspnea was reported by at least 29 % of patients, and fatigue by over 50 %. Depression was reported infrequently, with over half of patients at each visit reporting "none"; moderate or severe depression was reported in only 2.5-9.3 and 3.4-6.2 % of patients, respectively. The average number of moderate/severe symptoms increased with proximity to death; 84 % reported moderate/severe fatigue in the last 3 months of life, compared to 48 % at ≥12 months from death (P = 0.007). Patients with aNSCLC face a significant symptom burden, which increases with proximity to death. Symptom type and severity vary by proximity to death, but even patients without overt CACS report significant functional symptoms throughout. We recommend an individualized approach to palliative symptom intervention in advanced lung cancer, based on detailed symptom assessment and tracking.
    Supportive Care in Cancer 03/2015; DOI:10.1007/s00520-015-2699-4 · 2.50 Impact Factor
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    ABSTRACT: Patient-reported outcome (PRO) measures, such as quality of life, have been associated with relevant clinical end points and are prognostic for survival outcomes in a variety of solid cancers in adults. In the past few years, PROs have garnered a greater influence as established and clinically relevant measures that could alter the current paradigm of practice-changing therapeutic advances, as it has been recognized that classic clinical end points do not accurately portray a full appreciation of the benefits, risks and costs of therapy. In this Review, we comprehensively assess the correlation of PROs with treatment response and survival, and explore tumour-related and patient-centric composite end points in patients with cancer participating in clinical trials. Comparisons or composite end points that consider tumour-related and PRO components might help health-care providers, patients with cancer and decision makers to better understand the total clinical benefit of therapeutic interventions.
    Nature Reviews Clinical Oncology 03/2015; DOI:10.1038/nrclinonc.2015.29 · 15.70 Impact Factor
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    ABSTRACT: Pillars4Life is an educational program that teaches coping skills to cancer patients in a virtual group setting; it was recently implemented at 17 hospitals across the USA. The cost-effective, scalable, and assessable Pillars4Life curriculum targets psychosocial resources (e.g., self-efficacy and coping skills) as a means to reduce symptoms (e.g., depression, anxiety, and posttraumatic stress) and enhance quality of life. Cancer patients were recruited from hospitals that received the LIVESTRONG Community Impact Project Award to enroll in a pilot study of Pillars4Life. Consenting participants met with a certified instructor weekly for 10 weeks in a virtual environment; the manualized intervention trained participants in personal coping skills. Longitudinal assessments over 6 months were assessed using validated instruments to determine changes in Pillars4Life targeted resources and outcomes. Multiple linear regression models examined the relationship between changes in targeted resources and changes in outcome from baseline to 3 months post-intervention. Participants (n = 130) had the following characteristics: mean age of 56 ± 11 years, 87% women, 11% non-Caucasian, and 77% with college degree. At 3- and 6-month follow-up, mean scores improved on all key outcome measures such as depression (Patient Health Questionnaire), anxiety (Generalized Anxiety Disorder), posttraumatic stress (Posttraumatic Stress Disorder Checklist), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and well-being (Functional Assessment of Cancer Therapy-General) from baseline (all p < 0.01); results were most pronounced among participants who reported ≥4/10 on the Distress Thermometer at baseline (all p < 0.001). Changes in each targeted resource were associated with 3-month improvements in at least one outcome. Participation in the Pillars4Life program was associated with statistically and clinically significant improvements in scores on pre-specified outcomes and targeted resources. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Psycho-Oncology 01/2015; DOI:10.1002/pon.3750 · 4.04 Impact Factor
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    ABSTRACT: Women with early-stage breast cancer face the complex decision to undergo one of three equally effective oncologic surgical strategies: breast-conservation surgery with radiation (BCS), mastectomy, or mastectomy with breast reconstruction. With comparable oncologic outcomes and survival rates, evaluations of satisfaction with these procedures are needed to facilitate the decision-making process and to optimize long-term health. Women recruited from the Army of Women with a history of breast cancer surgery took electronically administered surgery-specific surveys, including the BREAST-Q© and a background survey evaluating patient-, disease-, and procedure-specific factors. Descriptive statistics and regression analysis were used to evaluate the effect of procedure type on breast satisfaction scores. Overall, 7,619 women completed the questionnaires. Linear regression revealed that women who underwent abdominal flap, or buttock or thigh flap reconstruction reported the highest breast satisfaction score, scoring an average of 5.6 points and 14.4 points higher than BCS, respectively (p < 0.0001 and p = 0.027, respectively). No difference in satisfaction was observed in women who underwent latissimus dorsi flap reconstruction compared with those who underwent BCS. Women who underwent implant reconstruction reported scores 8.6 points lower than BCS (p < 0.0001). Those with mastectomies without reconstruction or complex surgical histories scored, on average, 10 points lower than BCS (p < 0.0001). Women who underwent autologous tissue reconstruction reported the highest breast satisfaction, while women undergoing mastectomy without reconstruction reported the lowest satisfaction. These findings emphasize the value of patient-reported outcome measures as an important guide to decision making in breast surgery and underscore the importance of multidisciplinary participation early in the surgical decision-making process.
    Annals of Surgical Oncology 12/2014; 22(2). DOI:10.1245/s10434-014-4246-9 · 3.94 Impact Factor
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    ABSTRACT: We searched MEDLINE, EMBASE and the Cochrane Controlled Trials Register to determine whether oxygen relieves dyspnoea in mildly or non-hypoxemic COPD and included 18 randomised controlled trials (431 participants) in the meta-analysis using Cochrane methodology. Oxygen therapy reduced dyspnoea when compared with medical air; standardised mean difference -0.37 (95% CI -0.50 to -0.24; I(2)=14%). In a priori subgroup and sensitivity analyses, dyspnoea was reduced by continuous oxygen during exertion but not short-burst oxygen therapy. Continuous exertional oxygen can relieve dyspnoea in mildly or non-hypoxemic COPD, but evidence from larger clinical trials is needed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to
    Thorax 12/2014; DOI:10.1136/thoraxjnl-2014-205720 · 8.56 Impact Factor
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    ABSTRACT: Purpose To identify insured services that are most important to Medicare beneficiaries with cancer and their family caregivers when coverage is limited. Methods A total of 440 participants (patients, n = 246; caregivers, n = 194) were enrolled onto the CHAT (Choosing Health Plans All Together) study from August 2010 to March 2013. The exercise elicited preferences about what benefits Medicare should cover for patients with cancer in their last 6 months of life. Facilitated sessions lasted 2.5 hours, included 8 to 10 participants, and focused on choices about Medicare health benefits within the context of a resource-constrained environment. Results Six of 15 benefit categories were selected by > 80% of participants: cancer care, prescription drugs, primary care, home care, palliative care, and nursing home coverage. Only 12% of participants chose the maximum level of cancer benefits, a level of care commonly financed in the Medicare program. Between 40% and 50% of participants chose benefits not currently covered by Medicare: unrestricted cash, concurrent palliative care, and home-based long-term care. Nearly one in five participants picked some level of each of these three benefit categories and allocated on average 30% of their resources toward them. Conclusion The mismatch between covered benefits and participant preferences shows that addressing quality of life and the financial burden of care is a priority for a substantial subset of patients with cancer in the Medicare program. Patient and caregiver preferences can be elicited, and the choices they express could suggest potential for Medicare benefit package reform and flexibility. (C) 2014 by American Society of Clinical Oncology
    Journal of Clinical Oncology 08/2014; 32(28). DOI:10.1200/JCO.2013.54.2605 · 17.88 Impact Factor
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    ABSTRACT: Concerns about unsustainable costs in the US Medicare program loom as the number of retirees increase and experiences serious and costly illnesses like cancer. Engagement of stakeholders, particularly cancer patients and their families, in prioritizing insured services offers a valuable strategy for informing Medicare coverage policy. We designed and evaluated a decision exercise that allowed cancer patients and family members to choose Medicare benefits for advanced cancer patients.
    BMC Health Services Research 07/2014; 14(1):315. DOI:10.1186/1472-6963-14-315 · 1.66 Impact Factor
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    ABSTRACT: Little is known about the association between patient-oncologist discussion of cancer treatment out-of-pocket (OOP) cost and medication adherence, a critical component of quality cancer care.
    Journal of Oncology Practice 05/2014; 10(3):162-7. DOI:10.1200/JOP.2014.001406
  • Journal of Surgical Oncology 04/2014; 109(5). DOI:10.1002/jso.23515 · 2.84 Impact Factor
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    ABSTRACT: Health care-related costs and satisfaction are compelling targets for quality improvement in cancer care delivery; however, little is known about how financial burden affects patient satisfaction.Methods.This was an observational, cross-sectional, survey-based study assessing patient-reported financial burden (FB). Eligible patients were ≥21 years with solid tumor malignancy and were receiving chemotherapy or hormonal therapy for ≥1 month. The Patient Satisfaction Questionnaire Short-Form assessed patient satisfaction with health care. Subjective FB related to cancer treatment was measured on a 5-point Likert scale.Results.Of 174 participants (32% response rate), 47% reported significant/catastrophic FB. Participants reported highest satisfaction with interpersonal manner and lowest satisfaction with financial aspects of care. In adjusted analysis, high FB was negatively associated with general satisfaction (coefficient: -.29), satisfaction with technical quality (coefficient: -.26), and satisfaction with financial aspects of care (coefficient: -.62). Older age was associated with higher scores in all satisfaction subscales except patient-physician communication and financial aspects. Annual household income of <$20,000 was associated with lower satisfaction scores in all subscales except time spent with doctor. High FB was not associated with patient satisfaction scores for accessibility and convenience, communication, interpersonal manner, or time spent with doctor.Conclusion.FB is a potentially modifiable correlate of poor satisfaction with cancer care including general satisfaction and satisfaction with the technical quality of care. Addressing cancer-associated FB may lead to improved satisfaction, which in turn can influence adherence, outcomes, and quality of life.
    The Oncologist 03/2014; 19(4). DOI:10.1634/theoncologist.2013-0374 · 4.54 Impact Factor
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    ABSTRACT: Efficient dietary interventions for patients with hypertension in clinical settings are needed. To assess the separate and combined influence of a physician intervention (MD-I) and a patient intervention (PT-I) on dietary intakes of patients with hypertension. A nested 2×2 design, randomized controlled trial conducted over 18 months. A total of 32 physicians and 574 outpatients with hypertension. MD-I included training modules addressing the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure hypertension management guidelines and lifestyle modification. PT-I included lifestyle coaching to adopt the Dietary Approaches to Stop Hypertension (DASH) eating pattern, reduce sodium intake, manage weight, increase exercise, and moderate alcohol intake. Dietary intakes were measured by the Block Food Frequency Questionnaire. Concordance with the DASH dietary pattern was estimated by a DASH score. The main effects of MD-I and PT-I, and their interaction, were evaluated using analysis of covariance. After 6 months of intervention, MD-I participants significantly increased intakes of potassium, fruits, juices, and carbohydrate; decreased intake of fat; and improved overall dietary quality as measured by the Healthy Eating Index. PT-I intervention resulted in increased intakes of carbohydrate, protein, fiber, calcium, potassium, fruits and fruit juices, vegetables, dairy and Healthy Eating Index score, and decreased intakes in fat, saturated fat, cholesterol, sodium, sweets, and added fats/oils/sweets. In addition, PT-I improved overall DASH concordance score. The change in DASH score was significantly associated with the changes in blood pressure and weight at 6 months. At 18 months, most changes reversed back toward baseline levels, including the DASH score. Both MD-I and PT-I improved eating patterns at 6 months with some sustained effects at 18 months. Even though all dietary changes observed were consistent with the DASH nutrient targets or food group guidelines, only the PT-I intervention was effective in improving the overall DASH concordance score. This finding affirms the role of medical nutrition therapy in long-term intensive interventions for hypertension risk reduction and weight management and underlines the need for development of maintenance strategies. Furthermore, this study emphasizes the importance of collaborations among physicians, registered dietitians and other dietetics practitioners, and lay health advisors while assisting patients to make healthy behavior changes.
    Journal of the American Academy of Nutrition and Dietetics 08/2013; DOI:10.1016/j.jand.2013.06.343 · 2.44 Impact Factor
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    ABSTRACT: The relationship between prescription medication adherence and financial burden is understudied, particularly in patients seeking financial assistance. We conducted a cross-sectional survey to examine the association between patient-reported prescription medication nonadherence and financial distress. Eligible patients were adults receiving treatment for solid malignancies enrolled between June 2010 and May 2011 from the HealthWell Foundation, a national copay assistance program. Nonadherence was defined as taking less medication than prescribed because of cost, not filling or partially filling a prescription because of cost, or taking medications prescribed for others. Logistic regression assessed associations between medication nonadherence and patient-reported, subjective financial distress. Among 164 participants, 45% reported cost-related medication nonadherence. Four percent took medications prescribed for another person, 22% took less medication than prescribed, 25% filled a partial prescription, and 27% did not fill a prescription, all as a result of cost. Nonadherent participants were more likely than adherent participants to reduce spending on basics like food and clothing to pay for medication (P = .01), and borrow and/or use credit to pay for medications (P < .01). In adjusted analyses, financial distress did not change odds of nonadherence (odds ratio [OR] = 1.60; 95% CI, 0.71 to 3.60). Having a prescription drug plan (OR = 0.27; 95% CI, 0.09 to 0.83) and older age (OR = 0.48; 95% CI, 0.27 to 0.85) decreased odds of nonadherence. Being unemployed increased odds of nonadherence (OR = 6.28; 95% CI, 1.60 to 24.64). Cost-related medication nonadherence was prevalent among cancer patients who sought financial assistance. Further investigation is needed to understand predictors of prescription medication adherence, a key component of quality care.
    Journal of Oncology Practice 08/2013; DOI:10.1200/JOP.2013.000971
  • David C Currow, Gregory P Samsa, Amy P Abernethy
    Journal of pain and symptom management 12/2012; 44(6):e2-e4. DOI:10.1016/j.jpainsymman.2012.09.003 · 2.74 Impact Factor
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    ABSTRACT: CONTEXT: Evidence-based approaches are needed to improve the delivery of specialized palliative care. OBJECTIVES: The aim of this trial was to improve on current models of service provision. METHODS: This 2×2×2 factorial cluster randomized controlled trial was conducted at an Australian community-based palliative care service, allowing three simultaneous comparative effectiveness studies. Participating patients were newly referred adults, experiencing pain, and who were expected to live >48 hours. Patients enrolled with their general practitioners (GPs) and were randomized three times: 1) individualized interdisciplinary case conference including their GP vs. control, 2) educational outreach visiting for GPs about pain management vs. control, and 3) structured educational visiting for patients/caregivers about pain management vs. control. The control condition was current palliative care. Outcomes included Australia-modified Karnofsky Performance Status (AKPS) and pain from 60 days after randomization and hospitalizations. RESULTS: There were 461 participants: mean age 71 years, 50% male, 91% with cancer, median survival 179 days, and median baseline AKPS 60. Only 47% of individuals randomized to the case conferencing intervention received it; based on a priori-defined analyses, 32% of participants were included in final analyses. Case conferencing reduced hospitalizations by 26% (least squares means hospitalizations per patient: case conference 1.26 [SE 0.10] vs. control 1.70 [SE 0.13], P=0.0069) and better maintained performance status (AKPS case conferences 57.3 [SE 1.5] vs. control 51.7 [SE 2.3], P=0.0368). Among patients with declining function (AKPS <70), case conferencing and patient/caregiver education better maintained performance status (AKPS case conferences 55.0 [SE 2.1] vs. control 46.5 [SE 2.9], P=0.0143; patient/caregiver education 54.7 [SE 2.8] vs. control 46.8 [SE 2.1], P=0.0206). Pain was unchanged. GP education did not change outcomes. CONCLUSION: A single case conference added to current specialized community-based palliative care reduced hospitalizations and better maintained performance status. Comparatively, patient/caregiver education was less effective; GP education was not effective.
    Journal of pain and symptom management 10/2012; DOI:10.1016/j.jpainsymman.2012.02.024 · 2.74 Impact Factor
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    ABSTRACT: We sought to determine the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements for studies of anticancer targeted therapies conducted in the off-label prescribing setting. As a part of a federally funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to compendia published in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and presence of COI and funding disclosure statements. Among the 69 included studies, prevalence of COI and funding disclosures was low, at 33% and 58% respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high-impact-factor journals (P < .001), large study sample size (P = .001), enrollment exclusively in the United States (P = .04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (P = .03). Disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anticancer targeted therapies was low and did not increase substantially over time.
    Journal of Oncology Practice 09/2012; 8(5):298-302. DOI:10.1200/JOP.2011.000523
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    ABSTRACT: Patterns of medical resource use near the end of life may differ across modes of death. The aim of this study was to characterize patterns of inpatient resource use and direct costs for patients with heart failure (HF) who died of sudden cardiac death (SCD), HF, other cardiovascular causes, or noncardiovascular causes during the last year of life. Data were from a randomized trial of exercise training in patients with HF. Mode of death was adjudicated by an end point committee. Generalized estimating equations were used to compare hospitalizations, inpatient days, and inpatient costs incurred during the final year of life in patients who died of different causes, adjusting for clinical and treatment characteristics. Of 2,331 patients enrolled in the trial, 231 died after ≥1 year of follow-up with an adjudicated mode of death, including 72 of SCD, 80 of HF, 34 of other cardiovascular causes, and 45 of noncardiovascular causes. Patients who died of SCD were younger, had less severe HF, and incurred fewer hospitalizations, fewer inpatient days, and lower inpatient costs than patients who died of other causes. After adjustment for patient characteristics, inpatient resource use varied by 2 to 4 times across modes of death, suggesting that cost-effectiveness analyses of interventions that reduce mortality from SCD compared to other causes should incorporate mode-specific end-of-life costs. In conclusion, resource use and associated medical costs in the last year of life differed markedly in patients with HF who experienced SCD and patients who died of other causes.
    The American journal of cardiology 07/2012; 110(8):1150-5. DOI:10.1016/j.amjcard.2012.05.059 · 3.43 Impact Factor
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    ABSTRACT: The standard clinical approach for reducing cardiovascular disease risk due to dyslipidemia is to prescribe changes in diet and physical activity. The purpose of the current study was to determine if, across a range of dietary patterns, there were variable lipoprotein responses to an aerobic exercise training intervention. Subjects were participants in the STRRIDE I, a supervised exercise program in sedentary, overweight subjects randomized to 6 months of inactivity or 1 of 3 aerobic exercise programs. To characterize diet patterns observed during the study, we calculated a modified z-score that included intakes of total fat, saturated fat, trans fatty acids, cholesterol, omega-3 fatty acids, and fiber as compared with the 2006 American Heart Association diet recommendations. Linear models were used to evaluate relationships between diet patterns and exercise effects on lipoproteins/lipids. Independent of diet, exercise had beneficial effects on low-density lipoprotein cholesterol particle number, low-density lipoprotein cholesterol size, high-density lipoprotein cholesterol, high-density lipoprotein cholesterol size, and triglycerides (P < .05 for all). However, having a diet pattern that closely adhered to American Heart Association recommendations was not related to changes in these or any other serum lipids or lipoproteins in any of the exercise groups. We found that even in sedentary individuals whose habitual diets vary in the extent of adherence to AHA dietary recommendations, a rigorous, supervised exercise intervention can achieve significant beneficial lipid effects.
    American heart journal 07/2012; 164(1):117-24. DOI:10.1016/j.ahj.2012.04.014 · 4.56 Impact Factor
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    ABSTRACT: Background: Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. Purpose: To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. Data Sources: MEDLINE, CINAHL, PsycINFO, Web of Science, and the Cochrane Database of Systematic Reviews through January 2011. Study Selection: Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. Data Extraction: Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. Data Synthesis: 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n = 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n = 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n = 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. Limitations: Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. Conclusion: Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. Primary Funding Source: Agency for Healthcare Research and Quality.
    Annals of internal medicine 04/2012; DOI:10.1059/0003-4819-157-1-201207030-00450 · 16.10 Impact Factor
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    ABSTRACT: To catalogue study designs used to assess the clinical effectiveness of CDSSs and KMSs, to identify features that impact the success of CDSSs/KMSs, to document the impact of CDSSs/KMSs on outcomes, and to identify knowledge types that can be integrated into CDSSs/KMSs. MEDLINE®, CINAHL®, PsycINFO®, and Web of Science®. We included studies published in English from January 1976 through December 2010. After screening titles and abstracts, full-text versions of articles were reviewed by two independent reviewers. Included articles were abstracted to evidence tables by two reviewers. Meta-analyses were performed for seven domains in which sufficient studies with common outcomes were included. We identified 15,176 articles, from which 323 articles describing 311 unique studies including 160 reports on 148 randomized control trials (RCTs) were selected for inclusion. RCTs comprised 47.5 percent of the comparative studies on CDSSs/KMSs. Both commercially and locally developed CDSSs effectively improved health care process measures related to performing preventive services (n = 25; OR 1.42, 95% confidence interval [CI] 1.27 to 1.58), ordering clinical studies (n = 20; OR 1.72, 95% CI 1.47 to 2.00), and prescribing therapies (n = 46; OR 1.57, 95% CI 1.35 to 1.82). Fourteen CDSS/KMS features were assessed for correlation with success of CDSSs/KMSs across all endpoints. Meta-analyses identified six new success features: Integration with charting or order entry system. Promotion of action rather than inaction. No need for additional clinician data entry. Justification of decision support via research evidence. Local user involvement. Provision of decision support results to patients as well as providers. Three previously identified success features were confirmed: Automatic provision of decision support as part of clinician workflow. Provision of decision support at time and location of decisionmaking. Provision of a recommendation, not just an assessment. Only 29 (19.6%) RCTs assessed the impact of CDSSs on clinical outcomes, 22 (14.9%) assessed costs, and 3 assessed KMSs on any outcomes. The primary source of knowledge used in CDSSs was derived from structured care protocols. Strong evidence shows that CDSSs/KMSs are effective in improving health care process measures across diverse settings using both commercially and locally developed systems. Evidence for the effectiveness of CDSSs on clinical outcomes and costs and KMSs on any outcomes is minimal. Nine features of CDSSs/KMSs that correlate with a successful impact of clinical decision support have been newly identified or confirmed.
    Evidence report/technology assessment 04/2012;
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    ABSTRACT: Although coronary artery disease (CAD) is the leading cause of death for women in the United States, treatment studies to date have primarily enrolled men and may not reflect the benefits and risks that women experience. Our systematic review of the medical literature assessed the comparative effectiveness of major treatment options for CAD specifically in women. The comparisons were (1) percutaneous coronary intervention (PCI) versus fibrinolysis/supportive pharmacologic therapy in ST elevation myocardial infarction (STEMI), (2) early invasive versus initial conservative management in non-ST elevation myocardial infarction (NSTEMI) or unstable angina, and (3) PCI versus coronary artery bypass surgery (CABG) versus optimal medical therapy in stable or unstable angina. The endpoints assessed were clinical outcomes, modifiers of effectiveness by demographic and clinical factors, and safety outcomes. MEDLINE(R), PubMed(R), Embase(R), and Cochrane Database of Systematic Reviews. Randomized controlled trials published in English from January 1, 2001, to December 12, 2011, comparing the treatment options for CAD listed above and containing sex-specific outcomes. Clinical outcomes were classified as short term (</=30 days), intermediate term (1 year), or long term (>1 year). Random-effects meta-analysis was performed for studies with similar outcomes measured at similar time points. Twenty-eight comparative studies contributed evidence about effectiveness, modifiers of effectiveness, or safety for the comparisons described above. For women with STEMI, five studies showed a reduction in composite outcomes (primarily death/MI/stroke) at 30 days for PCI over fibrinolysis (odds ratio [OR] 0.50; 95% CI, 0.36 to 0.72; high strength of evidence [SOE]); there was insufficient evidence for assessing outcomes at 1 year. For women with NSTEMI or unstable angina, the included studies, although not showing statistical significance, suggested a benefit of early invasive over initial conservative management for the composite outcome of primarily death/MI at 6 months and 1 year (2 studies, OR 0.77; CI, 0.28 to 2.12; low SOE; 5 studies, OR 0.78; CI, 0.54 to 1.12; low SOE). Evidence, however, suggested a small benefit of initial conservative management at 5 years (2 studies, OR 1.05; CI, 0.81 to 1.35). Given the small suggested benefit at 5 years, the wide confidence interval crossing 1, and the trend favoring early invasive therapy suggested at earlier time points and across time points in men-we cannot support firm conclusions (insufficient SOE). For women with stable angina randomized to revascularization (PCI or CABG) or medical therapy, three studies showed a reduction in the composite outcome of death/MI/repeat revascularization at 5 years for revascularization with either PCI (OR 0.64; CI, 0.47 to 0.89; moderate SOE) or CABG (OR 0.56; CI, 0.32 to 0.96; low SOE). For stable and unstable angina trials comparing PCI with CABG, two studies suggested a nonsignificant benefit of PCI in mortality at 30 days (low SOE). At 1 year and beyond, although suggestive of a benefit of CABG in for the composite outcomes of death/MI/stroke for women, this finding was not statistically significant and represented wide confidence intervals (low SOE at 1 year and at >2 years). Five studies assessed modifiers of effectiveness in women due to demographic factors (>/=65 or >/=80 years of age) or clinical factors (risk stratification or diabetes). Strength of evidence for modifiers of effectiveness for STEMI, NSTEMI, and stable/unstable angina was insufficient. Four studies assessed safety outcomes in women: two STEMI studies (PCI versus fibrinolysis) and two NSTEMI studies (PCI versus CABG) assessed transfusion rates, incidence of intracranial hemorrhage, and bleeding rates. Strength of evidence for safety outcomes for all the CAD presentations was insufficient. From a limited number of studies reporting results for women separately from the total study population, our findings confirm current practice and evidence for care in one of the three areas evaluated. For women with STEMI, we found that an invasive approach with immediate PCI is superior to fibrinolysis for reducing cardiovascular events, which is similar to findings in previous meta-analyses combining results for both women and men. For women with NSTEMI or unstable angina, evidence suggested that an early invasive approach reduces cardiovascular events; however, it was not statistically significant. Previous meta-analyses of studies comparing early invasive with initial conservative strategies on a combined population of men and women showed a significant benefit of early invasive therapy. We also found that the few trials reporting sex-specific data on revascularization compared with optimal medical therapy for stable angina showed a greater benefit with revascularization for women, while the men in the study fared equally well with either treatment. In contrast, previous meta-analyses that combined results for men and women found similar outcomes for either treatment. Limitations include a small number of trials with data for women available for meta-analysis, varying definitions of composite outcomes, and variable timing of followup. Future studies should collect and report clinical outcomes and harms in women by treatment strategy and at each followup time point-including subgroup data on important demographic and clinical factors that may modify clinical effectiveness-so that firmer conclusions can be reached about the risk and benefit of these therapies in women.

Publication Stats

9k Citations
1,099.01 Total Impact Points


  • 1991–2014
    • Duke University Medical Center
      • • Department of Biostatistics and Bioinformatics
      • • Duke Clinical Research Institute
      • • Division of Hematology
      • • Division of General Internal Medicine
      • • Department of Medicine
      • • Department of Community and Family Medicine
      Durham, North Carolina, United States
    • Duke University
      • • Department of Medicine
      • • Center for Health Policy & Inequalities Research
      Durham, North Carolina, United States
  • 1988–2014
    • University of North Carolina at Chapel Hill
      • • Department of Epidemiology
      • • Department of Medicine
      North Carolina, United States
  • 2011
    • Dongguk University
      Sŏul, Seoul, South Korea
  • 2008
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
  • 2002
    • Kansas City VA Medical Center
      Kansas City, Missouri, United States
  • 2000
    • BASF Corporation
      Florham Park, New Jersey, United States
  • 1997
    • Campbell University
      North Carolina, United States